Conscious Sedation vs General Anesthesia in TAVR Patients

M

Montefiore Medicine Academic Health System

Status

Withdrawn

Conditions

Aortic Stenosis

Treatments

Procedure: General Anesthesia
Procedure: Conscious Sedation

Study type

Interventional

Funder types

Other

Identifiers

NCT03084978
2016-7021

Details and patient eligibility

About

This is a randomized controlled trial investigating the effect of general anesthesia versus conscious sedation on operative times in patients undergoing transcatheter aortic valve replacement.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Signed informed consent, signed Health Insurance Portability and Accountability Act (HIPAA) documentation)
  • Age over 18 years of age.
  • Women of child bearing age must have a negative urine or serum pregnancy test.
  • Clinical indication for a transfemoral aortic valve replacement.
  • English or Spanish speaking
  • No evidence of neurological impairment as defined by a NIHSS ≤ 1 and modified Rankin scale (mRS) ≤ 2 within 7 days prior to randomization.

Exclusion criteria

  • BMI > 40
  • Diagnosis of severe obstructive sleep apnea based on previous polysomnography, with severe defined as an apnea-hypopnea index (AHI) >30 episodes/hr.
  • High risk for aspiration such as severe esophageal disease (e.g. achalasia, gastroparesis, etc).
  • Inability to lie supine for more than 30 minutes.
  • Marginal femoral vessels with concern for possible conversion to transapical or transaortic access.
  • Patient refusal
  • Patient involved in another research study
  • Psychiatric condition precluding ability to provide informed consent
  • History of clinical stroke within 3 months prior to randomization

Trial design

0 participants in 2 patient groups

General Anesthesia
Active Comparator group
Description:
Subjects will undergo general anesthesia with endotracheal intubation.
Treatment:
Procedure: General Anesthesia
Conscious Sedation
Experimental group
Description:
Subjects will undergo conscious sedation anesthesia.
Treatment:
Procedure: Conscious Sedation

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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